• Don’t become discouraged if you volunteer for a clinical trial but are turned down.

“Once we contact a potential volunteer, we need to see if the person is eligible,” said Dr. Howard Taras from UC San Diego’s Clinical & Translational Research Institute. “They go through the process, but they’re in the wrong age group or for some reason they aren’t eligible for the trial. We want them to try again.”

Clinical trial lingo

Clinical study or trial: An investigation using human subjects to discover how beneficial or effective an intervention (drug, therapy or behavioral change) may be.

Arms: The assigned groups of participants in a particular clinical study.

Community health workers: Public health workers who have an understanding of the community they serve. Some are specifically trained to be clinical study recruiters.

Control group: The arm of a trial that gets the standard treatment, no treatment or a placebo.

Double blind: In this type of trial, neither the subjects nor investigators know which participants have been given which interventions.

Eligibility criteria: The standards that qualify willing participants for a particular clinical study. Age is a common criterion.

Experimental group: In a randomized trial, the arm that receives the new or experimental treatment.

Good clinical practice: An international ethical and scientific quality standard for clinical studies, protecting subjects’ rights and confidentiality.

Healthy volunteers: People without disorders or diseases needed to participate in many studies, often offering comparison to those with the condition.

Human subject: The individual, healthy or not, participating in a clinical trial.

Informed consent form: After reviewing the relevant information provided in the consent form, the subject signs it in order to participate in the study.

Institutional review board: An independent group of professionals that reviews and approves clinical trials, ensuring ethical standards and appropriate informed consent documents. All reputable clinical trials have been approved by an IRB.

Investigator: A physician, nurse, pharmacist or other health care professional who administers or dispenses a clinical trial’s treatment. The principal investigator is responsible for the overall conduct of the study.

Multicenter: A trial being conducted at several sites at once.

Open-label: In this type of study, all parties (patient, physician and study coordinator) are informed of who are receiving which treatments.

Paid trial: One of the small number of clinical trials that pay participants for their time.

Phases: The steps in clinical trials, going from Phase 1 with a small group of people being tested, to increasingly larger groups in Phase 2 and 3. In Phase 4, also called a post-marketing surveillance study, information is collected to determine other markets for a drug or to continue checking on its efficacy and any side effects.

Placebo: A substance without active ingredients that resembles the actual drug being investigated. Often the control group is unknowingly taking a placebo.

By the numbers

Of the general U.S. public recognizes the importance of clinical research in the advancement of medical science

85%

Of clinical trials face delay due to limited participation

8-10

YEARS

Length of time it takes for a drug to go from lab to clinical practice

F rom pain relievers and anti-inflammatories to statins and diuretics, most of the drugs we take for granted today were made possible through clinical trials.

But, outside of health professionals, most people have only a vague notion about clinical trials. According to Boston-based CenterWatch, which provides data and information analysis on clinical trials, 94 percent of the general U.S. public recognizes the importance of clinical research in the advancement of medical science. But 75 percent say they have little to no knowledge about clinical research and the participation process. The Michael J. Fox Foundation for Parkinson’s Research states that 85 percent of clinical trials face delays due to limited participation.

Through using human subjects, clinical trials help researchers determine whether a drug, lifestyle change or new device works.

“Trials range from filling out a questionnaire to peeing in a cup,” said Dr. Howard Taras, the director of community resources at UC San Diego’s Clinical and Translational Research Institute. “It can be an intervention program on smoking, a sleep study or taking an injection or a tablet. Each person gets specialized treatment.”

Some clinical trials can last up to three years. Some involve getting poked, prodded or inconvenienced. But, no matter how long or how uncomfortable, participation is a vital contribution.

“Every single patient wants the diagnostic test they get to be accurate, whether they have prostate or breast cancer or are just getting blood tests,” Taras said. “The only way to get it is to have extensive research done first.

“Other than aspirin, almost every medication has had to go through research. None of it would happen without people to try it on. We have the responsibility to chip in so we and our children can benefit from these advances.”

Jeffree Itrich, director of recruitment and communications at the UC San Diego-based Alzheimer’s Disease Cooperative Study offers a historical example.

“People used to frequently drop dead from heart attacks, but researchers found that plaque was blocking off arteries and that cholesterol was the culprit,” she said. “Statin drugs were tested and developed to keep cholesterol at good levels. That’s a primary reason why people now live with heart disease and don’t die of heart attacks nearly as often.”

Pros and cons

“Is it good for patients? It’s hard to know,” said Dr. A. Grant Kingsbury, a former clinical research coordinator and study-site monitor for pharmaceutical companies. “Some patients are just recycled from study to study. Sometimes it isn’t a clear cross-section of patients. UCSD has a lot of patients and a large database to go through, so those studies have a broader reach.”

CTRI community engagement manager Rodney von Jaeger’s main job is to make that reach even broader.

“We work with community organizations, which are the closest to the priorities of the community,” von Jaeger said. “For a high blood pressure trial, for example, we’ll try to partner with senior groups.”

ADCS, the research consortium of about 80 institutions nationwide, devotes a lot of time and energy to spreading the word.

Kingsbury’s ambivalence about research trials is not just about lack of diversity in the participant population.

“Before clinical trials, there’s a lot of harm done to animals — mice, rats, even monkeys,” he said. “That’s a negative about research that can yield a drug that is overwhelmingly positive for people. Is it worth that to find a drug that helps humans?

“It’s big business for the drug companies,” he added, noting that he wouldn’t discourage a patient considering a trial. “I guess it’s a business-side philosophy against moral issues.”

The reality is scores of clinical trials are being conducted in San Diego, a major center of health sciences. UC San Diego alone has an annual average of 200 new and 400 ongoing clinical trials. Palomar Health, on the other hand, usually runs around 30 clinical studies a year.

“It costs a billion dollars and takes between eight and 10 years for a drug to go from the lab to clinical practice,” said Dr. Richard Just, chairman of the Palomar Health Investigational Review Committee and medical director for the Research Institute at Palomar Health. “It’s all financed by pharmaceutical companies. From my vantage point, there’s an overshoot; the high prices go on and on, but they’ve got to recoup the expenses, otherwise we can’t continue research.”

Over the years, rules and regulations have been developed to protect participants (see accompanying box).

“A very important part of the process is informed consent,” CTRI’s von Jaeger stressed. “People interested (in a clinical trial) learn everything they’ll be asked to do, the benefits or risks, who’s responsible for unexpected costs and how much time it’ll take. They can ask whatever questions they have. They evaluate it and decide.”

Altruism and hope

Retired U.S. Navy pilot William Ware had great plans for his 70s. He and his wife Suzanne were looking forward to taking several five- to six-week trips annually.

But about a year ago, the Coronado resident began noticing some changes in his health.

“I had memory losses which were more severe than just forgetting to buy some particular thing at the grocery store.” Ware, 72, said. “I was on a trip without my wife and my habit was always to call her at home every morning. I couldn’t remember her name. We’d been married 47 years. It was a hammer blow.”

After being diagnosed with Alzheimer’s disease and trying different medications, with minimal success, Ware entered a drug trial at UC San Diego.

“My wife and I had some hard decisions to make — whether to travel or do this test,” he said. “I’ll continue with the program with hope that we can arrange traveling around it. It’s restrictive time-wise — it needs to be administered every 30 days.”

Ware realizes chances of the trial having positive effects for him are slim.

“My ultimate hope is that they could find something to reverse this. But in reality, I know that’s not likely to happen,” he said. “I’m pretty sure it would be too late to benefit me, but it may help somebody else avoid where I am right now.”

This attitude is common among people who have few alternatives, Itrich said.

“Altruism is a large factor. A research study may be a way for them to get treatment,” she said. “But ultimately people don’t want their children and grandchildren to go through this.”

In some fields, a trial can provide a participant hope or relief. Palomar Health’s Just has seen that occasionally happen with cancer patients.

“In oncology, we may see a patient not respondent after using multiple known drugs. They’re placed in Phase 1, testing a small number of patients,” Just said. “It has occurred that a patient’s tumor is slowly shrinking and the patient is tolerating the drug. The company will make it available as long as it is working.”